Cleared Traditional

GLUCOSE-HK TEST

K931890 · Em Diagnostic Systems, Inc. · Chemistry
Jul 1993
Decision
98d
Days
Class 2
Risk

About This 510(k) Submission

K931890 is an FDA 510(k) clearance for the GLUCOSE-HK TEST, a Hexokinase, Glucose (Class II — Special Controls, product code CFR), submitted by Em Diagnostic Systems, Inc. (Gibbstown, US). The FDA issued a Cleared decision on July 22, 1993, 98 days after receiving the submission on April 15, 1993. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K931890 FDA.gov
FDA Decision Cleared SESE
Date Received April 15, 1993
Decision Date July 22, 1993
Days to Decision 98 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code CFR — Hexokinase, Glucose
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1345

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